Safety Associate - Pharmacovigilance

Job Overview

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Essential Functions

• •To Prioritize and complete the assigned trainings on time.
• •Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• •To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information
• •Database entry
• •Coding AE and Products, writing narratives, Literature related activities as per internal/project timelines.
• •Ensure to meet quality standards per project requirements.
• •Ensure to meet productivity and delivery standards per project requirements.
• •Creating, maintaining and tracking cases as applicable to the project plan.
• •Identify quality problems, if any, and bring them to the attention of a senior team member.
• •To mentor new teams members, if assigned by the Manager.
• •Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• •100% compliance towards all people practices and processes
• •Perform other duties as assigned.

Qualifications

• •Bachelor’s degree in Life sciences or a related field (mandatory)
• •Fluency in English and Spanish (mandatory) (will be evaluated)
• •1 or 2 years of pharmacovigilance experience will be highly valued (desirable)
• •Experience with Safety Databases will be highly valued (ARGUS or others) (desirable)
• •Knowledge of applicable global, regional, local clinical research regulatory requirements. (desirable)
• •Excellent attention to detail and accuracy.
• •Good working knowledge of Microsoft Office and web-based applications.
• •Strong organizational and time management skills, with the ability to multitask and manage competing priorities and deadlines.
• •Strong verbal/written communication skills. Intermediate
• •Self-motivated and flexible. Intermediate

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.